Implantable device for internal urinary control

ABSTRACT

The present invention relates to a method for implanting an implantable apparatus for obtaining urinary control and emptying of the urinary bladder, thereby preventing from or treating involuntary urinary retention. In general terms, the apparatus comprises an expandable member adapted to be implanted inside the urinary bladder of the patient for discharging urine, and a control device for controlling the volume of the expandable member. The control device is adapted to be connected to the expandable member through the wall of the urinary bladder.

This application is a continuation of U.S. application Ser. No.15/837,478, filed Dec. 11, 2017 which is a continuation of U.S.application Ser. No. 13/123,082, filed Jul. 4, 2011,

which is the U.S. national phase of International Application No.PCT/SE2009/051132, filed Oct. 9, 2009, which designated the U.S. andclaims the benefit of U.S. Provisional Application Nos. 61/227,831 filedon Jul. 23, 2009 and priority from Swedish patent application no.0802154-5 filed Oct. 10, 2008, the entire contents of each of which arehereby incorporated by reference in this application.

FIELD OF INVENTION

The present invention relates to an implantable apparatus for obtainingurinary control and emptying of the urinary bladder, thereby preventingfrom or treating involuntary urinary retention. More particularly, theinvention relates to an implantable controlled hydraulic system fordischarging urine from the urinary bladder following displacement ofhydraulic fluid.

BACKGROUND OF INVENTION

Urinary dysfunction commonly caused by spinal cord injuries involvesinvoluntary urinary retention, a condition which associated with urinaryinfections, renal damages or damages to the urinary tract. A commontreatment of urinary retention is continuous or intermittentcatheterization. Besides the inconvenience for the patient, cathetersalways represent a risk of acquiring infections. Alternatively suggestedtherapies include electric stimulation of the urinary bladder forproviding muscle contraction and bladder emptying (see e.g. U.S. Pat.No. 6,393,323). Electric stimulation of the bladder needs considerationto that the urinary sphincter is stimulated to contraction byelectricity and pulsed stimulation will become necessary which, however,may lead to uncontrolled squirts of urine through the urethra. U.S. Pat.No. 4,044,401 discloses a totally artificial urinary bladder applied tothe urethra and linked to the ureters. This artificial bladder isemptied by a manually expandable balloon. However, the subcutaneouslyplaced reservoir of a sufficient size to empty the bladder would beunrealistically large. From this disclosure, it is evident that there isneed for an implanted apparatus for a patient with an intact bladderthat is convenient and compliant without any manual operations.Furthermore, such an apparatus needs to be designed with considerationto how the most exposed implanted parts shall be placed in a better wayinside the body and also replaced with a minimum of intervention in thepatient. The present invention intends to outline an apparatus thatmeets such requirements.

DESCRIPTION OF INVENTION

In general terms the present invention relates to an apparatus fortreating urinary retention of a patient by discharging urine from theurinary bladder, comprising an expandable member adapted to be implantedinside the urinary bladder of the patient, and a control device forcontrolling the volume of the expandable member. The control device isadapted to be connected to the expandable member through the wall of theurinary bladder. As a result of the expansion of the expandable memberurine is discharged from the urinary bladder through the urethra.

It will be evident from the present invention to be described as followsthat the term “control device” has a meaning including both hydraulicand electric components of the apparatus assisting with the urinarydischarge from the bladder. These components include both implantablecomponents and components intended to be outside the patient's body. Inthis context it should be observed that the control device could bedeviated into a hydraulic control device and an electric control device.The electric control device may then include power supply and electricalcontrol functions as well as a wireless energy receiver. The externalcontrol device could also be described as the external control unit fortransmitting wireless energy and receiving feedback information fromimplanted components. Therefore in any place in this document describingthe control device this term could be replaced by any of the forgoing,whenever relevant. In one embodiment the control device comprises aninternal control unit comprising at least one of a subcutaneously placedswitch, an electronic circuit, a motor or a pump, wherein said internalcontrol unit is operable from the outside of the patient's body.

The expandable member is preferably releasably attached to the controldevice with a detachable coupling. For this purpose the expandablemember, preferably is provided with a first mating part fitting with asecond mating part of the control device. The mating parts can be acombination of male/female parts which together establish a releasabledetachable coupling that readily attaches or detaches the expandablemember and the control device. The mating parts can together provide asnap lock coupling that simplifies the replacement of the expandablemember through the urethra. However, various embodiments of mating partsthat can provide a detachable coupling is conceivable in the presentcontext, as long as they present a reliable and convenient way attachingand releasing the control device and the expandable member. Accordingly,the expandable member preferably is designed with a capacity to assumean essentially cylindrical elongated shape which admits itstransportation through urethra assisted with a suitable invasiveinstrument. The expandable member, as inserted for implantation cancomprise a bellows or a similar structure undergoing controlledexpansion and collapse. Preferably, the expandable member ishydraulically controlled and comprises a cavity for hydraulic fluid andthe control device comprises a bladder operating reservoir for hydraulicfluid. The expandable member and the control device are accordinglyadapted to be hydraulically connected through the wall of urinarybladder. For this purpose, the control device preferably comprises atube to establish hydraulic connection and for transporting thehydraulic fluid between the bladder operating reservoir and the cavity.The detachable coupling can in one embodiment be connectable to thehydraulic connection and its mating part establish a connection betweenthe expandable member and the bladder operating reservoir so hydraulicfluid can be transported to and from the expandable member fordischarging urine and when the urinary bladder is refilled,

The control device of the apparatus preferably comprises an operationdevice for transporting hydraulic fluid to and from the cavity and thebladder operating reservoir. In one mode of operation, the expandablemember is adapted to be emptied by the pressure exerted by urine of theurinary bladder to transport the hydraulic fluid from the cavity to thebladder operating reservoir. The operation device is capable oftransporting hydraulic fluid to cavity of the expandable member toobtain a suitable urinary pressure for discharging urine. Preferably aurinary pressure of at least 50 cm water pressure for discharging urineis obtainable. Preferably the operation device is a powered pump.Further, the operation device can comprise or being connected to aninjection port, to calibrate the amount of hydraulic fluid. Theoperation device can also be manually operated by an injection portwhich is operated from outside the body by filling or emptying saidinjection port.

In addition, the apparatus can comprise implantable restriction devicesadapted to close the ureters when discharging urine from the urinarybladder in order to prevent any urinary backflow towards the kidneys.The restriction devices preferably are adapted to open and close theureters are hydraulically operable by hydraulic fluid. In a suitableembodiment the operating hydraulic fluid is displaced from the bladderoperating reservoir. For this purpose, the bladder operating reservoircan comprise a sealed expandable/collapsible section for the restrictiondevice operating hydraulic fluid. Preferably, these restriction devicesopen and close by the activity of the operation device.

The apparatus can also comprise a restriction device adapted to open andclose the urethra to assist patients having an impaired urinarysphincter function. Restriction devices suitable for the urinary tractand wireless control of such devices are further described in EuropeanPatents Nos. EP 1253880; EP 1284691 and EP 1263355, incorporated here asreferences.

The control device comprises a control assembly adapted to be implantedsubcutaneously or in the abdominal cavity in the patient for connectionto other parts of the control device. The control assembly comprises asource of energy for powering the operation device and other energyconsuming parts of the control device. These parts are further describedin the context of the system according to invention comprising therecited apparatus. The control assembly can further comprise aninjection port for receiving hydraulic fluid, connected to the bladderoperating reservoir.

The apparatus can also comprise an implantable pressure sensor formeasuring the urinary pressure in the urinary bladder direct orindirect, such as measuring the pressure inside the implantable member.

The hydraulic fluid can comprise an agent for counteracting microbialgrowth, such as an antibiotic.

In order to further assist urinary discharge, the control device canfurther comprise an implantable device for electrically stimulatingmuscles of the urinary bladder to contract the same, to cooperate withthe expandable member to discharge urine from the urine bladder.Preferably, the electrically stimulating device comprises a plurality ofelectrode strips attached to muscles of the urinary bladder.

In one alternative, the apparatus can comprise a second hydraulicconnection between the expandable member and the bladder operatingreservoir. The second connection is dimensioned so that the pumpspumping volume capacity is significantly much larger than the emptyingcapacity of said second connection, when open. According to thisalternative arrangement, the expandable member is adapted to be emptiedby the pressure exerted by urine of the urinary bladder to transport thehydraulic fluid from the cavity to the bladder operating reservoir bysaid second connection. In a special embodiment, the second connectionis a passageway in the detachable coupling that is established when thetwo mating parts are joined when bringing the expandable member togetherwith the control device. With such an arrangement, the second connectionmay remain open when the main hydraulic connection is closed.

The present invention also relates to a method of implanting thedescribed apparatus, which comprises inserting a needle-like tube intothe abdomen of the patient; filling the abdomen with gas through saidtube, thereby expanding the abdominal cavity; placing at least twolaparoscopic trocars in the patient's body and inserting a camerathrough one of said trocars into the abdomen; inserting at least onedissecting tool through a trocar and dissecting an area of at least oneportion of the urinary bladder of patient; incising an opening in theurinary bladder wall; placing an expandable member inside the urinarybladder; placing a control device outside the urinary bladder; andinterconnecting the expandable member and the control device with aninterconnection device. The method also comprises tunneling by suturingthe urinary bladder wall to itself in order to immobilize theinterconnecting device in a position penetrating the urinary bladderwall, while establishing a hydraulic connection between a cavity of theexpandable member and a bladder operating reservoir of the controldevice. Further, the method comprises placing a net adapted to supportin-growth of tissue with so it at least partially covers the tunneling.

The present invention also relates to an alternative method forimplanting the apparatus that comprises the steps of cutting the skin;dissecting an area of at least one portion of the urinary bladder ofpatient; incising an opening in the urinary bladder wall; placing anexpandable member inside the urinary bladder; placing a control deviceoutside the urinary bladder; and interconnecting the expandable memberand the control device with an interconnection device. The methodfurther may include at least one of the following steps;

placing a power source within the body for powering the control device;placing a hydraulic bladder operating reservoir and; placing a pumpwithin the body, for pumping fluid between the bladder operatingreservoir and the expandable member to discharge urine from the urinebladder.

The present invention further comprises a method of operating theapparatus that comprises activating a control assembly of the controldevice; increasing the volume of the expandable member; and dischargingurine through the urethra. The method can further comprise the step ofactivating the restriction devices to temporarily close the uretersand/or a step comprising activating the restriction device totemporarily release its restriction of the urethra or the neck of theurine bladder. In the method a control assembly can receive a signalfrom a pressure sensor measuring the urinary pressure in the urinarybladder or expandable member. The control assembly comprises an alarmsystem adapted to present an alarm signal for the patient, and is ableto activate said control assembly with a signal from a control unitcontrolled from external to the patient, such as a wireless remotecontrol or a subcutaneously implantable switch. The method can furthercomprise the step of activating a pump for transporting hydraulic fluidfrom said bladder operating reservoir to the expandable member.

The present invention still further relates to a method of replacing anexpandable member in the previous described apparatus for treatingurinary retention comprising the steps of inserting an instrumentadapted to operate on the expandable member through the urethra;releasing the expandable member from the control device; displacing thecollapsed expandable member with the instrument; and transporting thecollapsed expandable member through the urethra and out of the body.Further, the method comprises inserting a new, collapsed expandablemember through the urethra; displacing the expandable member to acoupling position with the control device; and attaching the expandablemember to the control device with a detachable coupling. The detachablecoupling comprises two mating parts, a first mating part on the proximalpart of the expandable member and a second mating part on the controldevice.

The present invention also relates to a system treating urinaryincontinence comprising the previously described apparatus. Parts orcomponents of system are described in the following sections of thedescription and should be regarded as applicable with any apparatusgenerally outlined in the previous part of the description.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus.

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus. In a preferredembodiment, the system comprises a hydraulic operation device foroperating the apparatus.

In one embodiment, the system comprises comprising a motor or a pump foroperating the apparatus.

The system can comprise a hydraulic device having an implantablehydraulic reservoir, which is hydraulically connected to the apparatus,wherein the apparatus is adapted to be non-invasively regulated bymanually pressing the hydraulic reservoir. Such a hydraulic device isintended to be linked to the control device and the expandable member ofthe apparatus as described in previous sections.

The system may comprise a wireless remote control for non-invasivelycontrolling the apparatus. The wireless remote control preferablycomprises at least one external signal transmitter and/or receiver, andpreferably further comprises an internal signal receiver and/ortransmitter implantable in the patient for receiving signals transmittedby the external signal transmitter or transmitting signals to theexternal signal receiver. The wireless remote control preferablytransmits at least one wireless control signal for controlling theapparatus. The wireless control signal can comprise a frequency,amplitude, or phase modulated signal or a combination thereof.Alternatively, the wireless remote control transmits an electromagneticcarrier wave signal for carrying the control signal. The control signalcan comprise one of the following: an electric field, a magnetic field,a combined electric and magnetic field. Alternatively, the controlsignal comprises an analogue signal, a digital signal, or a combinationof an analogue and digital signal.

The system can further comprise a wireless energy transmission devicefor non-invasively energizing implantable energy consuming components ofthe apparatus with wireless energy. In this respect, the wireless energycan comprise a wave signal selected from the following: a sound wavesignal, an ultrasound wave signal, an electromagnetic wave signal, aninfrared light signal, a visible light signal, an ultra violet lightsignal, a laser light signal, a micro wave signal, a radio wave signal,an x-ray radiation signal and a gamma radiation signal. Alternatively,the wireless energy can comprise one of the following: an electricfield, a magnetic field, a combined electric and magnetic field.

For its energizing, the system can comprise an implantable internalenergy source for powering implantable energy consuming components ofthe apparatus. In one embodiment, an external energy source fortransferring energy in a wireless mode for charging the internal energysource with energy transferred in the wireless mode. Such a system canfurther comprise a sensor or measuring device sensing or measuring afunctional parameter correlated to the transfer of energy for chargingthe internal energy source, and a feedback device for sending feedbackinformation from inside the patient's body to the outside thereof, thefeedback information being related to the functional parameter sensed bythe sensor or measured by the measuring device.

The system as described in any general terms can further comprise afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient, such asthe pressure in the urinary bladder, and a functional parameter relatedto the apparatus.

The system as described in any general terms can further comprise asensor and/or a measuring device and an implantable internal controlunit for controlling the apparatus in response to information beingrelated to at least one of a physical parameter of the patient sensed bythe sensor or measured by the measuring device and a functionalparameter related to the apparatus sensed by the sensor or measured bythe measuring device. The physical parameter is a pressure, such as thepressure in the urinary bladder or a motility movement.

The system as described in any general terms can further comprise anexternal data communicator and an implantable internal data communicatorcommunicating with the external data communicator, wherein the internalcommunicator feeds data related to the apparatus or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

In the embodiments where the system comprises an operation device foroperating the apparatus, the operation device can comprise a servodesigned to decrease the force needed for the operation device tooperate the apparatus, so the operation device instead acts a longerway, increasing the time for a determined action.

In the embodiments where the system comprises an operation device foroperating the apparatus and energy transmission device for transmittingwireless energy, such energy can be used in its wireless state todirectly power the operation device to create kinetic energy for theoperation of the apparatus, as the wireless energy is being transmittedby the energy-transmission device, i.e. the apparatus is directlypowered.

When the system comprises a wireless energy transmission device, it canfurther comprises an energy-transforming device for transforming thewireless energy transmitted by the energy-transmission device from afirst form into a second form energy. The energy-transforming devicedirectly powers implantable energy consuming components of the apparatuswith the second form energy, as the energy-transforming devicetransforms the first form energy transmitted by the energy-transmissiondevice into the second form energy. In this respect, the second form ofenergy comprises at least one of a direct current, pulsating directcurrent and an alternating current. The so described system can comprisean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator. In general terms the energy ofthe first or second form comprises at least one of magnetic energy,kinetic energy, sound energy, chemical energy, radiant energy,electromagnetic energy, photo energy, nuclear energy thermal energy,non-magnetic energy, non-kinetic energy, non-chemical energy, non-sonicenergy, non-nuclear energy and non-thermal energy.

The system as described in any general terms above can further comprisefurther comprising implantable electrical components including at leastone voltage level guard and/or at least one constant current guard.

When the system comprises a wireless energy transmission device it canfurther comprise an external control unit for controlling thetransmission of wireless energy from the energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto, the system furthercomprising a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the external control unit controls the transmissionof wireless energy from the external energy-transmission device, basedon the energy balance determined by the determination device. In onemode, the determination device is adapted to detect a change in theenergy balance, and the external control unit controls the transmissionof wireless energy based on the detected energy balance change. Inanother mode, the determination device is adapted to detect a differencebetween energy received by the internal energy receiver and energy usedfor the implantable energy consuming components of the apparatus, andthe external control unit controls the transmission of wireless energybased on the detected energy difference.

In a special embodiment, when the system comprises a wireless energytransmission device, the energy transmission device comprises a coilplaced externally to the human body. The system then further comprisesan implantable energy receiver to be placed internally in the human bodyand an electric circuit connected to power the external coil withelectrical pulses to transmit the wireless energy. The electrical pulseshave leading and trailing edges, and the electric circuit is adapted tovary first time intervals between successive leading and trailing edgesand/or second time intervals between successive trailing and leadingedges of the electrical pulses to vary the power of the transmittedwireless energy. The energy receiver receiving the transmitted wirelessenergy then has a varied power. In one mode, the electric circuit isadapted to deliver the electrical pulses to remain unchanged exceptvarying the first and/or second time intervals. In another mode, theelectric circuit has a time constant and is adapted to vary the firstand second time intervals only in the range of the first time constant,so that when the lengths of the first and/or second time intervals arevaried, the transmitted power over the coil is varied.

Embodiments of the system including a feedback device, as describedabove, can further comprise an implantable internal energy receiver forreceiving wireless energy. The energy receiver preferably has aninternal first coil and a first electronic circuit connected to thefirst coil. The system further comprises an external energy transmitterfor transmitting wireless energy, that preferably has an external secondcoil and a second electronic circuit connected to the second coil,wherein the external second coil of the energy transmitter transmitswireless energy which is received by the first coil of the energyreceiver. Such a system can further comprise a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.Alternatively, in such a system the feedback device can be adapted tocommunicate out the amount of energy received in the first coil as afeedback information, and wherein the second electronic circuit includesa determination device for receiving the feedback information and forcomparing the amount of transferred energy by the second coil with thefeedback information related to the amount of energy received in thefirst coil to obtain the coupling factors between the first and secondcoils. The energy transmitter preferably regulates the transmittedenergy in response to the obtained coupling factor. In one embodiment,the external second coil is adapted to be moved in relation to theinternal first coil to establish the optimal placement of the secondcoil, in which the coupling factor is maximized. In another embodiment,the external second coil is adapted to calibrate the amount oftransferred energy to achieve the feedback information in thedetermination device, before the coupling factor is maximized.

EXEMPLIFYING DESCRIPTION OF THE INVENTION

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,wherein:

FIG. 1 is a schematic picture of patient having the inventive apparatusimplanted.

FIG. 2a is a schematic picture of an embodiment of the apparatus asimplanted.

FIG. 2b is a section of the apparatus FIG. 2a illustrating thedetachable coupling between parts of the apparatus.

FIG. 3 is an illustration of the apparatus of FIG. 2a in its operatingmode of discharging urine from the urinary bladder through the urethra.

FIG. 4 is an illustration of the apparatus FIG. 2a when the urinebladder is refilled with urine, also showing a special embodiment wherethe bladder operating reservoir is hydraulically connected to the ureterrestriction devices.

FIG. 5 illustrates another embodiment of the apparatus.

FIG. 6 illustrates a system according to the invention, wherein thesystem schematically includes an apparatus of the invention implanted ina patient.

FIGS. 7-21 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 22 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 6.

FIG. 23 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 24 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 6.

FIG. 25 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIGS. 26-29, 30 a-c, 31, and 32 a-c show various ways of arranginghydraulic or pneumatic powering of an apparatus implanted in a patient.

By reference to FIG. 1 and FIG. 2a the apparatus has an expandablemember 20 with a cavity for accommodating hydraulic fluid that is placedinside the urinary bladder 30 which contains urine arrived from theureters 32A, 32B. A control device 50 operates the expansion and therebythe volume of the expandable member. The control device 50 has a controlassembly 52 connected to a bladder operating reservoir 54 for hydraulicfluid which is connected to the expandable member with aninterconnecting device 56 for transporting hydraulic fluid between thebladder operating reservoir 54 and the expandable member 20. A pump 53is supporting the fluid transportation. The interconnecting device 56 isa tube-shaped device surgically incised through the wall of the urinarybladder and attached thereto with tunneling technique whereby thebladder wall is sutured to itself. The interconnecting device issupported by the net 58 which seals fixates by admitting tissuein-growth. In FIG. 2a the interconnecting device 56 is attached to adetachable coupling 55 that attaches the bladder operating reservoirwith the expandable member as will be described below with FIG. 2b . Thecontrol assembly 52 is located in the patient and includes a number offunctional elements necessary for operating the apparatus, such as anoperating pump 529 for the hydraulic fluid, a source of energy 521 fordriving the operating pump and other energy consuming parts of theapparatus. An external energizer 60 transfers wireless energy to anenergy transforming device 522 so the source of energy 521 can besupplemented. An external control unit 70 provides wirelesscommunication with an internal control unit 523 for operating theapparatus. Also, the pressure sensor 57 is connected to a sensor controlfunction 524 of the control assembly. The control assembly 52 has aninternal part 52A including the mentioned functions and an external part52B which includes an injection port 521B and a manually operable switch522B. One or more parts of the control device may be implantedsubcutaneously or in the abdominal cavity or the pelvic region or anyother suitable place inside the body. The embodiment depicted in FIG. 2ais adapted for a patient suffering from a complication where the urinarysphincter is permanently closed. For this reason, the expandable member20 of the apparatus needs to exert a considerable pressure (about 60-80cm water pressure) to force urine out from the bladder and urine maythereby backflow through ureters 32A, 32B with potential risks fordamaging the kidneys. To prevent from any such complications, thecontrol device is provided with restriction devices 59A, 59B arranged totemporarily contract the ureters and close them during the operation ofdischarging urine with the expandable member. The restriction devicesare operated from the control assembly in manner to perform theirtemporary contraction during the discharge performance. Suitablemechanical or hydraulically operated restriction devices and theircontrol are described in more detail in European Patents Nos. EP1253880; EP 1284691; and EP 1263355. The urine pressure in the ureter isnormally around 50 cm water, however short term pressure increase ismost likely not damaging the kidneys and therefore the restrictiondevices 59A and 59B may be omitted.

When the pump 53 is not pumping to fill the expandable member and if thepassage-way 56 between the bladder operating reservoir and theexpandable member is free, then the expandable member is emptied byurine filling the bladder. Another alternative is that the pump 53starts in steps to empty the expandable member for example pressurecontrolled or controlled by any other input sensor as mentionedelsewhere. A second connection 56B is introduced between the expandablemember 20 and the bladder operating reservoir 54. The second connectionis adapted to admit transportation of fluid from the member 20 to thebladder operating reservoir when the connection is closed. If thepumping volume capacity is significantly much larger than the emptyingcapacity of the second connection this connection may always stand open,also when the pump 53 transports fluid from the bladder operatingreservoir 54 to the member 20. Introduction of the second connectionshall be regarded as an optional alternative of the apparatus.

FIG. 2b is closer view of the detachable coupling 55 in FIG. 2a and itstwo mating parts 55A and 55B. A first mating part 55A is a part of thecontrol device 50 and is connected to the bladder operating reservoir54. The second mating part 55B is arranged on the expandable member 20.The two mating parts are readily attachable and detachable in order toconveniently attach or detach the expandable member to the controldevice 50. Accordingly, the expandable member becomes readilyreplaceable by intervention through the urethra with a suitableinstrument. For this purpose the expandable member is capable ofassuming an essentially cylindrical elongated shape to conveniently passthrough the urethra. FIG. 2b also shows the second connection 56B as apart of the detachable coupling.

By reference to FIG. 2a and FIG. 3, the apparatus in operated byactivating the operating pump of the control assembly 54 which isoperable in response from a signal from a remote control 70. The controlassembly can also be connected to a pressure sensor 57 for monitoringthe urinary pressure of the bladder. Several different types of inputsensors may be used determining for example stretching or bending orpressure in the urine bladder wall or for example sensing volume orpressure inside the urine bladder. Most likely these sensors is onlyindirectly causing the bladder to be emptied by presenting an alarm forthe patient informing that it is time to empty the bladder. Such analarm is generated audible or visually. The remote control 70 maycontrol a subcutaneous switch 525 for controlling the emptying of thebladder or communicating via the body used as a wire or with wirelesscommunication. The pump now transports hydraulic fluid from the bladderoperating reservoir 54, through the interconnection device 56 to thecavity of the expandable member 20, which thereby increases in volume inthe urinary bladder and discharges urine through the urethra at apressure that overcomes the closing force of the urethral sphincter, sovoiding of the urinary bladder is accomplished. During this operationthe control assembly operates to close restriction device 59A, 59B toprevent any urinary backflow in the ureters. When the dischargingperformance is finished and the operating pump is inactive, therestriction devices 59A, 59B are released so urine can refill theurinary bladder. By the pressure of the refilled urine, the expandablemember 20 subsequently collapses to retain a shape as shown in FIG. 2when ready for a new performance as monitored by the pressure sensor.

Some patients having urinary retention also have urinary incontinence.In such a case a separate urinary sphincter is included in the system, arestriction device closing the urethra until the patient wants tourinate. In such a case lower pressure is needed to empty the bladderbecause the no force would be needed to open the sphincter by intrabladder pressure. In this case the restriction devices 59A and 59B maybe omitted.

The bladder operating reservoir 54 may be placed anywhere inside thebody, however preferable in the abdominal cavity, maybe placed onto theurine bladder or in the pelvic region. The amount of liquid in thebladder operating reservoir may be calibrated with fluid by using theinjection port 521B and a subcutaneous reservoir 526 placed inside thebody within reach from a special injection port needle. The subcutaneousreservoir may also be omitted and only the injection port may be used tofill and empty the expandable member.

With the described embodiment it is also conceivable to control theduration/force of the urine discharge process, e.g. that data from thepressure sensor measuring the urinary pressure or easier the pressureinside the expandable member in the bladder controls the operation pumpby logic in the control assembly. It should be noted that the expandablemember may be elastic or only flexible, within the used pressure insidethe same. FIG. 3 shows the apparatus of FIG. 2 (without the controldevice 50) when discharging urine. The restriction devices 59A, 59B nowclose the ureters 32A, 32B while urinary sphincter 59C is open. FIG. 4shows the apparatus of FIG. 3 when the urinary bladder is being refilledwith urine and hydraulic fluid is returned to the bladder operatingreservoir 54. The restriction devices 59A, 59B are now open whileurinary sphincter 59C is closed. FIG. 4 also shows an embodiment whereinthe restriction devices for ureters are hydraulically operated withhydraulic fluid from a special section of the bladder operatingreservoir. The hydraulic fluid for operating the restriction devices canbe displaced from the reservoir when the remaining section of thereservoir is filled as a consequence of the urinary pressure exerted onthe expandable member. FIG. 5 illustrates another embodiment of theapparatus of FIG. 2a . Here the bladder operating reservoir 54 ishydraulically connected to a pump 527 in the control assembly 52 whichoperates to pump hydraulic fluid to the expandable member 20.

It should be understood that the described embodiment can be modifiedwithin the scope of the appended claims.

FIG. 6 illustrates a system for treating urinary incontinence with anapparatus 10 of the present invention and generally described or asillustrated FIGS. 1 to 5. The system is placed in the abdomen of apatient. An implanted energy-transforming device 302 is adapted tosupply energy consuming components of the apparatus with energy via apower supply line 303. An external energy-transmission device 304 fornon-invasively energizing the apparatus 10 transmits energy by at leastone wireless energy signal. The implanted energy-transforming device1002 transforms energy from the wireless energy signal into electricenergy which is supplied via the power supply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 7 illustrates the system of FIG. 6 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 7,except that a reversing device in the form of an electric switch 1006operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 7,except that an operation device 1007 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 1002 and the apparatus 10. This operationdevice can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 10 shows an embodiment of the invention identical to that of FIG.7, except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 1009 back from the apparatus 10 to the fluidreservoir 1010 to return the apparatus to a starting position. Theimplanted energy-transforming device 1002 transforms wireless energyinto a current, for example a polarized current, for powering themotor/pump unit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 11 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shining device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the apparatus 10 to operate theapparatus, and another opposite direction in which the fluid is pumpedby the motor/pump unit 1009 back from the apparatus 10 to the hydraulicfluid reservoir 1013 to return the apparatus to a starting position.

FIG. 7 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 10. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming device 1002 via a power line 1020, thecapacitor 1017, which stabilizes the electric current, a power line 1021and the power line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 12 may be omitted. In accordance with another alternative, theaccumulator 1016 in this embodiment may be omitted.

FIG. 13 shows an embodiment of the invention identical to that of FIG.7, except that a battery 1022 for supplying energy for the operation ofthe apparatus 10 and an electric switch 1023 for switching the operationof the apparatus 10 also are implanted in the patient. The electricswitch 1023 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the battery 1022 is notin use, to an on mode, in which the battery 1022 supplies energy for theoperation of the apparatus 10.

FIG. 14 shows an embodiment of the invention identical to that of FIG.13, except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 10.

FIG. 15 shows an embodiment of the invention identical to that of FIG.14, except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 16 shows an embodiment of the invention identical to that of FIG.15, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 17 shows an embodiment of the invention identical to that of FIG.13, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the apparatus 10 (mechanically operated). Even simpler isto switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.

FIG. 18 shows an embodiment of the invention identical to that of FIG.24 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the apparatus 10.

FIG. 19 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 20 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the apparatus 10 via a subcutaneous electricswitch 1026. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 21 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 22 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 23 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10.

Moreover, the current condition of the patient may also be detected bymeans of suitable measuring devices or sensors, in order to provideparameters reflecting the patient's condition. Hence, suchcharacteristics and/or parameters may be related to the current state ofthe apparatus 10, such as power consumption, operational mode andtemperature, as well as the patient's condition reflected by parameterssuch as; body temperature, blood pressure, heartbeats and breathing.Other kinds of physical parameters of the patient and functionalparameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 h wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 22employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken intenally to specifically operatethe apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 22 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 23, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 24 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 22 and FIG. 24 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 25 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 25 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, LI, is included in the schematic FIG. 3; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 25and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 25 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil LI.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 8 could be incorporated in any of theembodiments of FIGS. 11-17, the hydraulic valve shifting device 1014 ofFIG. 11 could be incorporated in the embodiment of FIG. 10, and the gearbox 1024 could be incorporated in the embodiment of FIG. 9. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 22, 24 and 25identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train am varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises an external control unit for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the external control unit controls the transmissionof wireless energy from the external energy-transmission device, basedon the energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the external control unit controls the        transmission of wireless energy based on the detected energy        balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the external control unit controls the        transmission of wireless energy based on the detected energy        difference.    -   The external control unit controls the external        energy-transmission device to decrease the amount of transmitted        wireless energy if the detected energy balance change implies        that the energy balance is increasing, or vice versa, wherein        the decrease/increase of energy transmission corresponds to a        detected change rate.    -   The external control unit controls the external        energy-transmission device to decrease the amount of transmitted        wireless energy if the detected energy difference implies that        the received energy is greater than the used energy, or vice        versa, wherein the decrease/increase of energy transmission        corresponds to the magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 26-29 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 26 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 27 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 28 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 29 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 30a-c . InFIG. 30a , a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 25a , the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 30b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 31 and 32 a-c. The block diagramshown in FIG. 31 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 32a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 31a , the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.32a-c , the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

1.-85. (canceled)
 86. A method implanting an apparatus for treating aurinary retention of a patient by discharging urine from a mammalurinary bladder through a mammal urethra, comprising the steps of:cutting the skin of the patient; dissecting an area of at least oneportion of a urinary bladder of a patient; incising an opening in a wallof the urinary bladder; placing an expandable member inside the urinarybladder; placing a control device outside the urinary bladder, whereinthe control device is adapted to control the volume of the expandablemember for emptying the urinary bladder; and releasably interconnectingthe expandable member and the control device with an interconnectiondevice comprising a detachable coupling, to form a detachableinterconnection between the expandable member and the control devicethrough wall of the urinary bladder.
 87. The method according to claim86, wherein the detachable coupling comprises a first mating part and asecond mating part, the first mating part being arranged in a proximalpart of the expandable member and to fit with the second mating partarranged attached to the control device.
 88. The method according toclaim 86, wherein said detachable coupling is detachable in situ in thepatient.
 89. The method according to claim 86, wherein the step ofplacing a control device outside of the urinary bladder comprisessubcutaneously placing a switch in the patient.
 90. (canceled)
 90. Themethod according to claim 86, wherein: the expandable member ishydraulically controlled and comprises a cavity for hydraulic fluid; thecontrol device comprises an implantable bladder operating reservoir forhydraulic fluid, and wherein wherein the interconnecting devicecomprises an implantable tube to establish a hydraulic connection andfor transporting the hydraulic fluid between the bladder operatingreservoir and the cavity.
 91. The method according to claim 90, whereinthe expandable member is adapted to be emptied by a pressure exerted byurine of the urinary bladder transporting the hydraulic fluid from thecavity to the bladder operating reservoir.
 92. The method according toclaim 90, wherein the step of placing the control device comprisesplacing an implantable operation device for transporting hydraulic fluidto and from the cavity and the bladder operating reservoir, wherein theoperation device is capable of transporting hydraulic fluid to thecavity of the expandable member to obtain a suitable urinary pressurefor discharging urine.
 93. The method according to claim 92, wherein theoperation device is capable of transporting hydraulic fluid to thecavity of the expandable member to obtain a urinary pressure of at least50 cm water pressure for discharging urine.
 94. The method according toclaim 92, wherein the operation device is a powered pump.
 95. The methodaccording to claim 92, wherein the step of placing the operation devicecomprises subcutaneously placing an injection port in the body of thepatient, the injection port adapted to at least one of: calibrate anamount of hydraulic fluid or operating the expandable member.
 96. Themethod according to claim 95, wherein the hydraulic fluid comprises anagent for counteracting microbial growth.
 97. The method according toclaim 86, further comprising the step of dissecting a ureter, andplacing an implantable restriction device on the ureter so that therestriction device can close each ureter of a patient when dischargingurine from the urinary bladder.
 98. The method according to claim 97,wherein the restriction device is operable by hydraulic fluid housed ina cavity of the expandable member.
 99. The method according to claim 97,further comprising the step of placing a second reservoir in the body ofthe patient, and wherein the restriction device is operable by hydraulicfluid housed in the second reservoir.
 100. The method according to claim86, wherein the control device further comprises an implantable devicefor electrically stimulating muscles of the urinary bladder to contractthe same.
 101. The method according to claim 90, wherein the expandablemember is adapted to be emptied by at least one of: a pressure exertedby urine of the urinary bladder for transporting the hydraulic fluidfrom the cavity to the bladder operating reservoir, and a pressureexerted by urine of the urinary bladder to transport the hydraulic fluidfrom the cavity to the bladder operating reservoir by a secondconnection between the expandable member and the bladder operatingreservoir, sized such that a pumps pumping volume capacity is largerthan an emptying capacity of said second connection, when open, whereinthe expandable member is adapted to be emptied by the pressure exertedby urine of the urinary bladder to transport the hydraulic fluid fromthe cavity to the bladder operating reservoir by said second connection.102. The method according to claim 86, wherein the control devicecomprises an internal control unit configured to receive signals from awireless remote control.
 103. The method according to claim 86, furthercomprising placing an internal energy receiver in the body of thepatient, adapted to be energized non-invasively and wirelessly by anenergy transmission device from outside the patient's body.
 104. Themethod according to claim 86, further comprising placing a sensor in thebody of the patient for sensing at least one physical parameter of thepatient.
 105. The method according to claim 86, further comprisingplacing a sensor in the body of the patient for sensing at least onefunctional parameter related to the apparatus.